U.S. FDA Medical Device Powered Toothbrush Requirements
FDA Medical Device Definition: A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.
FDA Powered Toothbrush Label Requirements and Exceptions
FDA Powered Toothbrush Import Information
FDA Powered Toothbrush Detentions (Powered Toothbrush Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Powered Toothbrush Manufacturers (Powered Toothbrush Suppliers)
- Powered Toothbrush Distributors
- Powered Toothbrush Processors
- Powered Toothbrush Repackers
- Powered Toothbrush Relabelers
- Powered Toothbrush Exporters
- Powered Toothbrush Importers
For more information about Powered Toothbrush Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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